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BTT1023 in Psoriasis

NCT ID: NCT00871598

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-08-31

Brief Summary

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Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.

Detailed Description

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Conditions

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Plaque Psoriasis

Keywords

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plaque psoriasis BTT1023 safety pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intravenous, three infusions over three weeks

Single 0.3

Group Type EXPERIMENTAL

BTT1023

Intervention Type DRUG

Test challenge

Repeat 1.0

Group Type EXPERIMENTAL

BTT1023

Intervention Type DRUG

intravenous, three infusions over three weeks

Repeat 2.0

Group Type EXPERIMENTAL

BTT1023

Intervention Type DRUG

intravenous, three infusions over three weeks

Repeat 4.0

Group Type EXPERIMENTAL

BTT1023

Intervention Type DRUG

intravenous, three infusions over three weeks

Repeat 8.0

Group Type EXPERIMENTAL

BTT1023

Intervention Type DRUG

intravenous, three infusions over three weeks

Interventions

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BTT1023

intravenous, three infusions over three weeks

Intervention Type DRUG

Placebo

intravenous, three infusions over three weeks

Intervention Type DRUG

BTT1023

Test challenge

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index

Exclusion Criteria

* Seropositive for infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; Tuberculosis; Acute systemic infection;
* Treatment with a monoclonal antibody therapy within 12 weeks prior to study entry;
* An absolute indication for a known effective treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotie Therapies Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Biotie Therapies Corp.

Locations

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Biotie investigational site

Dresden, Dresden, Germany

Site Status

Biotie investigational site

Leipzig, Leipzig, Germany

Site Status

Biotie investigational site

Berlin, State of Berlin, Germany

Site Status

Biotie investigational site

Berlin, State of Berlin, Germany

Site Status

Biotie Investigational Site

Görlitz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BTT12-CD016

Identifier Type: -

Identifier Source: org_study_id